At a glance
ClinicalIndex Comparison Record- ✓Age 18–80 years
- ✓Probable or definite ALS by El Escorial criteria
- ✓Chronic progressive motor weakness onset <24 months
- ✓Manual muscle testing score <8
- ✕Renal disease (Creatinine >2.0) or other active systemic disease
- ✕Type I or Type II diabetes
- ✕History of cancer, except localized skin cancers or cervical carcinoma-in-situ with no recurrence within 3 years
- ✕Clinically significant cardiac disease within 6 months (myocardial infarction, angina, congestive heart failure)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Insulin-like Growth Factor-1 in Amyotrophic Lateral Sclerosis (ALS)
In Brief
A Phase 3 clinical trial evaluating Insulin like growth factor, type 1 and Placebo for Amyotrophic Lateral Sclerosis. Completed, enrolled 330 participants across 20 sites in 2 countries.
Detailed Summary
The purpose of this multicenter study is to determine if insulin-like growth factor-1 (IGF-I) slows the progressive weakness in amyotrophic lateral sclerosis (ALS) patients. Study participants will be followed for 2 years once enrolled. They will receive either placebo or the active IGF-I. Examinations will take place at approximately 6-month intervals.
Study Details
Timeline
Interventions
0.05 mg per kg body weight given subcutaneously twice daily
The placebo represented the inert suspension vehicle for the IGF-1. It was given as equal volume as the active drug based upon body weight, subcutaneously twice daily.